Month: October 2018

Acute Flaccid Myelitis

Acute Flaccid Myelitis is a polio-like illness that tends to start with symptoms of an upper respiratory tract illness and leads to flaccid paralysis.  There are more questions than there are answers, but Dr. Uzma Hasan, pediatric infectious disease specialist, walks us through what we do know so we can all be better prepared if we encounter this illness.  

Acute Flaccid Myelitis

Acute Flaccid Myelitis is a polio-like illness that tends to start with symptoms of an upper respiratory tract illness and leads to flaccid paralysis.  There are more questions than there are answers, but Dr. Uzma Hasan, pediatric infectious disease specialist, walks us through what we do know so we can all be better prepared if we encounter this illness.

EPISODE TRANSCRIPT

This is the transcript to the episode. This transcript was created by a talk to text application and the function of having this here is to improve the page search engine optimization. This transcript has not been proofread, so please listen to the episode and don’t read this. The information contained herein will inevitably contain inaccuracies that affect that quality of the information conveyed and the creator of this content will not be held liable for consequences of the use of the information herein.

Unknown Speaker  0:03
Welcome to the physicians guide to doctoring A Practical Guide for practicing physicians where Dr. Bradley Block interviews experts in and out of medicine to find out everything we should have learned while we were memorizing the Krebs cycle. The ideas expressed on this podcast are those of the interviewer and interviewee and do not represent those of their respective employers. This podcast is intended for medical professionals. The information is to be used in the context of your own clinical judgment. And those on this podcast accept no liability for the outcomes of medical decisions based on this information, as the radiologist like to say clinical correlation is required. This is not medical advice. And even though the magic of podcasting may make it seem like we’re speaking directly in your ears, this does not constitute a physician patient relationship. If you have a medical problem, seek medical attention
Unknown Speaker  1:00
On today’s episode we discussed the cute placid, my lightest, the polio like illness that has been in the news lately with infectious disease specialist, Dr. Umar Hassan to talk about what the cause may be, how it presents some of the workup management strategies, and current research with hope for the future.
Unknown Speaker  1:19
Welcome back to the physicians guide to doctoring. On today’s episode, we have Dr. Uzma Hassan. She’s a double boarded physician board in pediatrics and pediatric infectious disease and is currently the division head for pediatric infectious disease at St. Barnabas Hospital in New Jersey. Dr. son was willing to do this on short notice given the recent increase in episodes of acute flaccid, my lightest, so that’s what we’re going to talk about today. One of the functions of this podcast is to educate physicians about current events. And given the recent spike in cases. I think it’s important for physicians who see this and don’t see this necessarily To be familiar with it, because, as an outlier geologist, I’m not likely to see this, but that doesn’t mean that I won’t get questions from family, friends and possibly patients. So Dr. Khan was educated in medical school at the Agha Khan University, went on to residency at the Cleveland Clinic and completed her infectious disease fellowship at Northwestern and is currently like I said the division head of infectious disease at St. Barnabas Hospital in Jersey. So, Dr. Hassan, thank you so much for taking the time to speak with us today.
Unknown Speaker  2:31
Thank you so much for having me. So,
Unknown Speaker  2:34
as an old alarm geologist, it’s not likely that I’m going to see this but as a doctor, people might be asking asking me about it. So can you just give us some basics about what is acute flaccid mellitus?
Unknown Speaker  2:48
Yes, sure. So to placid my light is is actually a very rare illness or reported about one 1 million young adults and children and it is characterized by rapid onset of weakness or paralysis of one or more limbs. And usually these children or adults a wind up having some abnormality in their gray matter when we do imaging with MRI. Some of these children can present with grouping of their eyelids having some difficulty speaking, they can present with the facial group. And most of these patients will have an acute wireless illness with you know, running those upper respiratory infections symptom, sometimes gastrointestinal symptoms about a week prior to the onset of this paralysis.
Unknown Speaker  3:43
So it can affect a cranial nerve or a peripheral nerve. That’s correct. Does it usually affect a singular nerve or can it can it affect a number of nerves
Unknown Speaker  3:55
typically, the involvement is is mostly seen and in spinal cord is fixed multiple segments of the spinal cord at the same time. In the cases that be seen for some reason, the cervical part of the spinal cord seems to be involved more often, which means that some of these patients might end up with respiratory issues. That’s exactly right.
Unknown Speaker  4:17
Oh, so I thought as a little oncologist, I wouldn’t be seeing it. But if it’s a respiratory issue, sometimes they’ll call us for things like that, especially if someone is has been on a ventilator for a while and needs a tracheostomy. So so if you are let’s say, you’re someone who’s who’s more likely to see this initially like a pediatrician, a neurologist, infectious disease intensive lyst emergency medicine physician, how does this what what are some signs that will that should make this part of my differential?
Unknown Speaker  4:54
Very good question. So you know, most of the children who present with this illness will Have a proceeding illness or an upper respiratory infection, and then they will come in with a sudden onset of weakness of an arm or leg. They complain of a feeling of heaviness or being unable to move that extremity. And I think the key thing is that too, not to dismiss those symptoms, but to take them very seriously. Yeah, a lot of times, you know, children this age group will be labeled as feigning illness. And and I think the key thing to recognize is that this is a real entity. If we start seeing the child who is not wanting to move and extremity that, and especially in the context of a recent viral syndrome, we have to take that very seriously.
Unknown Speaker  5:45
So what in particular Am I looking for on it on exam? Right, are there any particular parts before we get into diagnostic tests?
Unknown Speaker  5:53
Yes, I think there’s a couple of things that you will see in the extremity is significant muscle weakness. The children that we have seen will not be able to move there will be involved arm or leg at all You will see absence of reflexes in that extremity. And typically you know you do not see any sensory symptoms. So they will not typically complain of tingling, or of your temptation and their extremity. Typically they have internet sensation, but the ability to move that extremity is what gets compromised. Is there anything that we might confuse this for? Yes, there’s a bunch of things that can can mimic acute facet my latest. Some of these children get evaluated for things like Jamboree, or Crohn’s or smile lighters. They can be evaluated for peripheral neuropathy or so. So there’s a bunch of things that can mimic q classic, my latest I think the key distinction distinguishing feature is what we find on imaging, as well as some of the CSR findings. To help us sort of weigh in on the diagnosis So, the CDC had has now classified attracted by lightest, the the group the cases as probable cases versus confirmed cases. The probable cases are labeled based on their spinal fluid finding in in the context of a child who has an exam that’s abnormal or paralysis of an extremity. If you see spinal fluid parasitosis, which means a white cell count of more than five on the spinal fluid. We label that as a probable case, and a confirmed case is when they have truly have abnormality of their gray matter on an MRI, and they are presenting with involvement of, you know, a vocal paralysis of a limb or so so that’s a confirmed case. What do we think is causing this? So you know, there’s been several viruses that have been previously implicated with to trusted my light is enterovirus. The 68 was implicated in the outbreak in 2014. And usually it’s the non polio, enteroviruses that sort of take the lead amongst other viruses that have been implicated in cases of the future acid. My light is there is the non polio enteroviruses, like I mentioned. Then there has been some cases described with Admiral virus. Some some cases described the herpes zoster with rabies, or so so, so but most commonly, it’s the non polio ankle viruses that have been implicated in cases of a to class of my lightest.
Unknown Speaker  8:38
Wow, that’s interesting because that’s something that’s been implicated in vestibular neuritis. Yes. Yeah. So, so, there there are some parallels are interesting. And what can we do for this what what is the house of medicine have for these patients?
Unknown Speaker  8:58
So, so amongst a limited number of cases that we have seen over the years or so, there’s been a bunch of modalities of treatment that have been tried patients have been given IBM, you know, globulin. They have been plasma for research has been tried in some cases or so, and, and variable outcomes. Pretty much treatment is done on a case by case basis and there’s really no data to back up one treatment versus another. The CDC and advisors use a use of steroids with caution in cases of a non political or non fully enterovirus related to class in my life. So, so steroids youth has been pretty much reserved as the cases that are really severe who have who have been a front acknowledge or recipe involvement, which is where we have used steroids but again advised caution with the use of steroids in this case scenario. Is it communicable
Unknown Speaker  10:02
because if it’s a virus, right, you shouldn’t you shouldn’t be seeing it in in clusters. But I don’t think of vestibular neuritis or Labyrinth itis as something that’s communicable right? You never see that spread through a household where every family member comes in at the same time with vertigo. It’s like it’s an isolated incident. So, very good question. Typically this disease is sort of confined to the host in which it is happening in. So you do not see clusters happening in the household or multiple memory family members of a household getting infected.
Unknown Speaker  10:35
So presumably though the virus was contagious, so you might have seen a bunch of family members get a cold at the same time but only one one person ends up with AFM. That’s it. That’s exactly right. The that you may see a symptomatic infection or you may see a milder form of infection and the other members in the household and you may have another household member wind up with a FM
Unknown Speaker  11:00
You have that’s been described where you’ll have more than one family member household member with with this?
Unknown Speaker  11:08
No, actually not. Typically, you will see a symptomatic illness and other household members. But you you will, you will it is typically just one member of the household who’s been who’s been symptomatic with AFM. There’s not been a cluster of AFM cases described in one one household
Unknown Speaker  11:26
focus. Okay, I misunderstood and so what what do we tell parents family members? If they’re if they’re concerned that you know, oh, my my child was exposed there was a kid in their class. Now you know, he’s my, my son has a runny nose. I’m worried that he’s going to develop AFM how what what can we say to those parents?
Unknown Speaker  11:53
I think the key message to get across is this is exceedingly rare and and you know, like Like the CDC discusses less than one in a million cases or so the and probably fewer related issues are much more common, or flu related deaths are much more common than you would see and a child having enterovirus related AFM. So I think it’s a constant reminder that that even though this is Block media attention, I think that there are other things that are that are bigger troublemakers than AFM is.
Unknown Speaker  12:30
That’s a great point actually, that this is an excellent teaching opportunity. So you have an anxious parent that comes in with a child with a with what seems like a cold and making sure that that child and the parent has both of both had their flu shot because that is is more likely to be problematic for them for something that’s that’s exceedingly rare like like FM. Are you familiar with any research That, that’s being done right now that might give us some, some hope for some more effective management strategies.
Unknown Speaker  13:07
Yeah, so a couple of things that are in the works. One is the CDC has has come up with has sort of following these patients long term. So so all the patients and from each state that gets a group ordered out there collecting specimens, identifying, you know, commonalities in between these patients, and then these children will get cracked long term to see how they recover. Interestingly, there has been some great research out of Children’s Hospital LA, were there the good looked at North comfort in the kids with AFM, who had persistent weakness. So depending on where they had involvement, they were offered surgery if they had Dr. paralysis, they were offered surgery actually of the five to six month mark. If they had one focal lemon movement, for example, a shoulder or elbow they would due north conference with them at the six to nine month mark and then if they had isolated one muscle involvement they did they did it around a year out from their initial presentation and their initial results are actually very promising. The has had some children who had significant than moment wars is now starting to still show some recovery and in muscle function and the children who’ve had these North conference done so I think that this is extremely promising. I also know that the Children’s Hospital of Philadelphia is taking this up. And and I think in the children who have extreme compromised and and lack of improvement, or lack of significant improvement, this is a very, very promising
Unknown Speaker  14:49
opportunity or promising
Unknown Speaker  14:53
method of treatment that’s out there and and something to do look for in the future business. How the Quran fair in the long run.
Unknown Speaker  15:04
That’s interesting that you that you brought this up that this is being done at Children’s Hospital in LA, because one of the guys doing this was a resident with me at Georgetown. I didn’t have residency at Georgetown and he was a plastic surgery resident. And I think he’s been actually featured on the news and he’s been posting on his Facebook page about this. Mitchell Surya SERUYA. So I’ll find out from him if we can post post a link to his department, so Children’s Hospital. So if you have a patient or you know somebody that has a compromised limb from AFM, it sounds like get them in touch with I guess it would be the plastic surgery department at CHOP or at Children’s Hospital la because there’s some there’s some promising work being done on on nerve transfers. Wow.
Unknown Speaker  16:01
That’s that’s, that’s amazing. That’s amazing that they’re doing these things.
Unknown Speaker  16:06
Are there any other questions that you’re getting from family member from from families or from other physicians that you think we haven’t covered yet?
Unknown Speaker  16:16
Yeah, I think the one other thing that they people ask is about the 60 of the flu vaccine in the context of these viral illnesses or so. You know, I always say that that flu is entirely if the children were vaccinated against flu, even if they were to have you in that season, they get a much more attenuated for both the illness so absolutely must be vaccinated. I think that’s the only doctor going to provide them with the additional level of protection. And and, and that’s the question that we get asked regarding regarding the FM patients. So far BB amongst the Colorado cluster, We had in 2014, you know, from my understanding from the CDC folks is that all of those children were vaccinated against the flu and they did. Absolutely fine. So though the CDC actually even advocates for vaccination in this population, and and that’s just something to put out there.
Unknown Speaker  17:19
Oh, yeah. I can’t imagine if if one of them had respiratory compromised, and then were to develop influenza that that would be horrible.
Unknown Speaker  17:27
Exactly. Wow.
Unknown Speaker  17:29
Well, this this has been extremely informative. I really appreciate you taking the time out of your, your busy day, which was so busy that you actually had a meeting this morning about this illness and and about your patients. Because this is such a such a relevant, relevant illness. Um, one more thing actually, that comes to mind. You mentioned that Colorado cluster in 2014. And part of my research for this podcast I listen to another podcast. where that was recorded in 2016. So there seems to be
Unknown Speaker  18:04
a pattern there. That’s exactly right. Would they have noticed is that we have a biannual peak to this illness. It looks like that. In 2014, there were about 120 confirmed cases in 3034 states. Between the timeframe from August to December, the following year 2015, there were just 22 confirmed cases in 17 states 2016, we saw rise again 149 confirmed cases in 39 states. And in 2017, we had a drop down to 33 cases in 16 states and 2018. Again, we’re back up so there are 62 confirmed cases in 22 states 155 case reports which are sort of pending confirmation from the CDC. So you’re absolutely right, we see a sort of a biennial pattern to the subtler
Unknown Speaker  19:00
Interesting, but but as you were saying, the likelihood of getting it one in a million
Unknown Speaker  19:07
influenza much higher. So when you do have parents that are bringing their children in, and you know, parents, we’re talking we’re just talking about children. What was the age group that’s affected by this?
Unknown Speaker  19:17
Very good question. The average age group for this year’s cluster has been around for years. We have seen a ages up to 17 years being reported out.
Unknown Speaker  19:30
or so but the it’s usually the younger age group that gets affected. Interesting. It’s almost it’s almost as if the illness knows what our cutoff is for what’s considered an adult. It’s gone up to 70. No reported, no reported 18 year olds. Well, exactly right. Dr. Hassan again, I really appreciate you taking the time out, making the excellent point that this is a good segue when a patient brings this up or a parent bring this up to make sure that they’re vaccinated for influenza. And giving us some some great clinical details on what we should keep in mind to look out for this and to educate our peers. So, thank you so much for taking the time. been very informative.
Unknown Speaker  20:11
pleasure. Thank you so much for having me.
Unknown Speaker  20:15
That was Dr. Bradley Block at the physicians guide to doctoring. Find all previous episodes on iTunes, Stitcher, Google podcasts, or wherever you get your podcasts and write us a review. You can also visit us on facebook@facebook.com slash physicians guide to doctoring. If you are interested in being a guest or have a question for a prior guest send a message or post a comment.
Transcribed by https://otter.ai

My Neck, My Back, My… Goodness

Seth Grossman, MD, a fellowship-trained orthopedic spine surgeon, discusses his most common consults; how to differentiate emergent spine injuries from less emergent issues, and why both patients and practitioners alike should be doing yoga, Pilates, and trying to fly like Superman.  

My Neck, My Back, My… Goodness

Seth Grossman, MD, a fellowship-trained orthopedic spine surgeon, discusses his most common consults; how to differentiate emergent spine injuries from less emergent issues, and why both patients and practitioners alike should be doing yoga, Pilates, and trying to fly like Superman.

TRANSCRIPT

This is the transcript to the episode. This transcript was created by a talk to text application and the function of having this here is to improve the page search engine optimization. This transcript has not been proofread, so please listen to the episode and don’t read this. The information contained herein will inevitably contain inaccuracies that affect that quality of the information conveyed and the creator of this content will not be held liable for consequences of the use of the information herein.

Unknown Speaker  0:03
Welcome to the physicians guide to doctoring A Practical Guide for practicing physicians where Dr. Bradley Block interviews experts in and out of medicine to find out everything we should have learned while we were memorizing the Krebs cycle. The ideas expressed on this podcast are those of the interviewer and interviewee and do not represent those of their respective employers. This podcast is intended for medical professionals. The information is to be used in the context of your own clinical judgment. And those on this podcast accept no liability for the outcomes of medical decisions based on this information, as the radiologist like to say clinical correlation is required. This is not medical advice. And even though the magic of podcasting may make it seem like we’re speaking directly in your ears, this does not constitute a physician patient relationship. If you have a medical problems, seek medical attention.
Unknown Speaker  0:57
On today’s episode, we speak to orthopedic spine surgeon, Dr. Seth Grossman about neck and back injuries, when to worry when not to worry, and why we should all be doing yoga polities. And once a day, get on our bellies and try to fly like Superman.
Unknown Speaker  1:13
Welcome back to the physicians guide to doctoring. On today’s episode, we have Dr. Seth Grossman, a spine surgeon in New York and New Jersey. Seth, thanks a lot for speaking with us today and helping to as you put it, demystify the spy.
Unknown Speaker  1:28
Sure. Thank you so much for having me.
Unknown Speaker  1:31
Could you just give us a little background on your training?
Unknown Speaker  1:34
Sure. So I went to medical school down in Philadelphia at Jefferson Medical College, which is now Sidney Kimmel, Medical College. After that, actually, before that I did I did some some graduate work in, in Computer Engineering, then maybe a little change in my career. So I went to medical school down at Jefferson and then I did my training at Albert Einstein Medical College monitor Medical Center. in the Bronx, and then I did a fellowship training in spine surgery at university California in San Diego. And since then I’m and again, I’m in private practice now I’m in a group. We have offices in Bergen County in North Jersey and then also in the city. few a few locations in the city. New York City, New York City. Yeah.
Unknown Speaker  2:20
This This podcast is international. So Oh, okay. Our audiences is broad. So, so Seth, you are going to talk to us about demystifying the spine. And so what are some of the things that you think all doctors, whether they treat related conditions, whether they’re referring physicians, like primary care physicians or er doctors, or treat things that are completely unrelated? What should all doctors know about the spine and I’ll give you an example. Let’s say you’re because in New York, New Jersey here we can get a lot of snow, your neighbor your neighbor is shoveling his driveway or her driveway and throws out his back, you know, whatever that means to me and otolaryngologist probably means something very different to you. And he he says, Hey, Doc, Hey Doc, because you know, everybody calls us Doc, if they can’t remember her name. Hey, Doc, just I just hurt my back. What do I do? So what do I asked him to make sure that it’s not a medical emergency? And should it not be? What do I tell him?
Unknown Speaker  3:28
Right? So it’s good question. So back pain in general is extremely common. It’s one of the most common reasons for loss of work in the United States. It’s one of the most common disabilities people have to miss work. And pretty much everybody at one point or another is going to figure out their their neck or their back. So something I see a lot in my office, something about, you know, a year, you know, people, my neighbors and such. So, it’s a very common occurrence and most of the time, vast majority of the time, you know, patients are going to be fine. The time is reassurance to your back you got arrested, you know, ice, you know, basically just kind of take it easy for a few days, maybe taking some incentives and that’s, you know 90% of the time patients will get better and within a period of time so red flags that you want to always you know look for is any kind of weakness or numbness So, just in general, the spine as an orthopedist, really any any specialties is a joint you know the series of joints in your back just like you know, your neck, your back just like just like a New York shoulder. So you can pull it you can strain it there are muscles and ligaments and tendons that can get injured and they heal much like any other joints. You know, the rest ice wrapping it that kind of thing babying it. The added complexity in terms of the spine is out there there are major nerves that run through that joint. So if something were to dislodge or press on a nerve, you know that can be dangerous and that you can damage that nerve and nerves. You know depending on how badly that they’re damaged or how much pressure is on the nerve not may not necessarily heal so you can end up God forbid with with neurologic dysfunction which can be permanent so that’s where I think everyone you know people get a little bit concerned a little bit over cautious with the spine so anyone who’s complaining of a neurologic type of a symptom that in my mind and you know in any doctor spine should be a red flag so doc I pulled out my back it’s killing me it’s throbbing my pain is 10 of the 10 I can barely walk that’s not uncommon complaint and that I see every day in my office and again I would say up in you know, 90% of those patients are are fine within a week. But you know, Doc, I pulled out my back shoveling my snow shoveling snow and now like, you know, my my foot is dragging and I can’t feel my toes, you know, is another sort of another added layer to that and that that may be something that is a little bit more serious.
Unknown Speaker  5:57
Okay, so numbness tingling, we can Does that warrant an immediate ER visit? Or should they follow up with you in the in the office?
Unknown Speaker  6:08
Yeah, it’s a good question. Certainly someone that should be seen soon. Whether or not it’s an emergency, I guess would depend on that the met you know, how bad the the neurologic dysfunction is?
Unknown Speaker  6:21
Nothing but loss of function probably is the is it? Would you say that that’s like a hard red line?
Unknown Speaker  6:27
Yeah, I mean, you know, you can lift your toes, that’s really an emergency, you have a little bit of tingling in your toes, that, you know, may not necessarily be something that has to be, you know, evaluated in the emergency room, especially during a snowstorm.
Unknown Speaker  6:42
So sounds like the differences sensory versus motor function. If it’s a motor function, it’s an emergency. If it’s sensory, then you can you know, wait for an office visit.
Unknown Speaker  6:54
Yeah, I would, I would say generally, obviously, that’s that’s a generalization but but clearly defined On the degree if it’s a little bit of numbness, a little bit of tingling, if you can’t feel your, any of your toes or you know something, but clearly, again, as the radiologist like to say, clinical correlation is required correlation Exactly. And then again, I’m sure everyone has heard the term called Aquinas syndrome which is which is a very rare but obviously, saddle anesthesia you know, bowel and bladder incontinence, anything like that, that happens soon after. an injury is also that’s that’s an immediate no trip to the emergency room. I will sort of preface that in that you know, patient versus back also has a little bit of prosthetic you know, prostate issues and has urinary retention that’s been ongoing for you know, 10 years and he takes medication for it doesn’t isn’t necessarily a quote Aquinas syndrome, and I think that we were very quick to, to jump to that. So loss of bowel and bladder basically where you can’t can’t feel or control your, your bowel and bladder movements. That’s an emergency and Having chronic issues constipation, you know, urinary retention is not there’s not a court appointed.
Unknown Speaker  8:07
If these things far preceded the injury then they’re probably unrelated to the injury.
Unknown Speaker  8:12
They’re probably unrelated. It’s probably not an emergency
Unknown Speaker  8:15
emergency or any of his his related. It’s not the fact that long history speaks to the lack of urgency. Okay, so let’s actually get back let’s get away from the urgent ones because those are the ones that that are going to be managed by you. What about the ones that aren’t urgent? So you you said Well, a few days of rest baby it for a little some end Said’s? What are you? Are you more specific than that? With your patients? You know, do you do you tell them more specific instructions? Three days, five days a week, wait until it feels better? Or is the data not just out there? And so, you know, I sometimes have trouble with this in my practice, like some people are sometimes looking For a specific answer, like a week, right? If I don’t feel better for my sinus infection in a week is it is it’s you know, doesn’t mean that the antibiotics aren’t working or three days, like they’re looking for something hard and fast. And the fact of the matter is, if you’re going to be giving someone a hard and fast number, you’re going to be kind of making it up, or are their recommendations.
Unknown Speaker  9:22
Right? By there’s a very good question. So I mean, there are recommendations in terms of the radiological societies are the biggest sites have ever released guidelines in terms of when you should say order an MRI, get, you know, get x rays, you know, do advanced testing and, and to be honest with you in today’s day and age, especially where we are in the New York, New Jersey area, I feel like patients, you know, pretty much demanding an MRI, you know, minute one when they when they walk into your office. So, you know, in terms of managing it again, even if it is, you know, I tell patients that You know, you pulled you back out, it’s probably a muscle sprain. But even if it is a herniated disc, which can be more serious, even that is going to get better with time and not necessarily need any kind of intervention. So, I generally try to, you know, I give patients either a course of events, heads or even, or even steroids for a week, and I haven’t time to come back and you know, rest, you know, if they’re, if they’re working, I give them a work note, especially if they do some manual labor. And I say within a week, if they’re not much better than we can go ahead and start ordering up tests and doing interventions, that kind of thing. So, roughly, you know, I basically say a week I don’t know that that’s an evidence based recommendation, but you got to give it a few days, everybody’s a little different. But typically, you know, most of the spasms and sprains will at least be 50% better, if not more in a week.
Unknown Speaker  10:50
And so does it improve outcomes to rest? It’s hurting or should they actually start to push their like will they recover from faster if they actually put limits like where’s where what I’m asking is where is that inflection point? Not necessarily time wise but time or symptomatic Lee or, like, you know, they shouldn’t lay on the couch until it feels 100% better. Right? So right.
Unknown Speaker  11:18
Where do you believe that and what point right sure so i mean i think if we extrapolate this out to a year right I think all patients are going to pretty much be better at that point whether they rested for two weeks or four weeks or I personally I definitely push you know, physical stretches. Walking you know, physical therapy definitely I think has a certainly in the short term definitely has a great effect that can really can really help but in the really immediate, you know, Doc, I just do my back out shoveling snow year is a time where I tell patients really just just rest. You don’t need to be lying in bed 24 hours a day to the point where you’re going to get a blood clot or something. like that but you know really just stay off your feet try to read you know I said minimize your your any kind of bending lifting and twisting for at least a few days and again after that then you can you know, you start to go do some stretches or see a therapist have a massage or something along those lines to try to get the muscle get the get the blood flowing to the muscles a little bit try to move a little bit for you know, stiffness and such.
Unknown Speaker  12:25
And is it is it any different for a neck injury or you’re saying this is not just lower back this is the entire spine? Yeah, I would say I would say you know, my advice is pretty much the same for the entire spine.
Unknown Speaker  12:41
You know, the neck
Unknown Speaker  12:43
can be a little more acute, you know, the spinal cord to get technical, you know, runs down your, your cervical thoracic spine, it ends around the top of your lumbar spine. So, most of the time you have a discrimination even a pinched nerve or ridiculous but the it’s a nerve root which is a little bit more tolerant of pressure and perturbation and then then the spinal cord itself. So if you have an injury where this you have pressure on the spinal cord that that also can, that can be a little bit more acute but in general, you know, just shoveling snow or sleeping wrong or you know minor trauma, you’re, you’re unlikely to have a major,
Unknown Speaker  13:23
you know, event where you’re having, you know, acute compression of your spinal cord.
Unknown Speaker  13:27
Now, have you just a little aside? There’s this text neck phenomenon. Have you seen this at all?
Unknown Speaker  13:36
Sure. I think that’s just, you know, this text neck is is just in the greater scope of 21st century living. So, we spend our days on the computer we’re on our phones in between, we’re basically always looking down and also as we age, our distance generate so your whole, you basically you’re focusing your whole, your whole body is is being pulled forward. And, yes, definitely a problem. And, you know, I, I talked to my patients about doing strengthening poses, specifically their posterior chain, so their extensive muscles, you know, working on flexibility but specifically with extension type activities because we tend to lose that naturally with age but even more so now in today’s society where all you know, our whole life is spent kind of crush over something.
Unknown Speaker  14:24
Can you give some examples of that? That sounds like something that is, is really great advice for human beings in general. And again, kind of the idea behind this podcast right, what what are the things that every doctor should know? That sounds like something every doctor should know. So what are some good exercises that we should
Unknown Speaker  14:46
maybe I can help? Yeah, so so anything where one thing that I tell a lot of patients is to do like a Superman, or basically if you you know, if you get a mad you put it on the ground, you lie in your stomach, and you put your arms out like you’re flying like this. Superman and then you basically you want to work on extending and lifting you know reaching your arms and your legs out and up as high as you can. And holding that for five seconds 10 seconds or you know doing or doing you know, doing set to that where you’re basically working on it on strengthening your extensors. That’s a really good one to do at home. If you have access to a gym I mean they have these these machines his boot him developer machines where you can go and you can you can also work on extension of your back of your neck that kind of thing. So the Superman is a good one you can also do it you know if you’re if you if you have a exercise ball, you can work on kind of, if you lean over the exercise ball with exercise ball in your stomach and you’re working on extending your your arms and your legs, you know, that kind of thing. I think it’s can be beneficial.
Unknown Speaker  15:47
So as a spine specialist when you are meeting with your patients and working on your electronic medical record, are you sitting on one of those balls?
Unknown Speaker  15:57
I wish no tonight unfortunately The Google ization of has not happened in medicine or no foosball tables or beer dispensers in the office, unfortunately. But I do tell patients so another thing to expand upon on top of just the Superman activities is yoga and polities. I tell everybody, I do it myself, I try and I tell all my patients to you don’t need to go too expensive. You don’t spend a lot of money you can go on YouTube, and just type in yoga exercises for your back. Just basic, the basic yoga poses like downward dog, Cobra, you know, cat cow, I don’t know how many Yogi’s are out there, but those are great exercises for your back and they all work on no flexibility, spine flexibility extensions.
Unknown Speaker  16:43
So I think it’s a it’s very beneficial.
Unknown Speaker  16:46
I think the classes also in terms of
Unknown Speaker  16:52
habit formation, right. I think I think going to those classes gives you a sense of accountability because you meet the other people there. Wait, where were you last week? So it gets you to keep going and then there’s a sense of community as well it’s Oh definitely definitely you can if you can incorporate that as part of your life and go a couple days a week I think dramatic improvement especially in patients chronic pain, you know, chronic
Unknown Speaker  17:19
you know, issues keratosis have their back and that gets certainly can be huge. But even if they can’t, you know, some patients don’t have the time or the means even putting on a video for half an hour, once or twice a week. But But definitely, if you can join a group and go to a class on a regular basis, I think patients will see dramatic improvements. So it’s rare to see to be honest with you. I say patients, you know, I tell them but, you know, it’s, it’s hard in today’s life, just to make time.
Unknown Speaker  17:45
Yeah, I hope to incorporate that into the podcast at some point and get some of these experts on habit development in here. So that when we do give advice to our patients, it can be in a way that is realistic. Stick where we can expect them, you know, it is a realistic expectation that they will take the advice because we want them to do all of these things, but how can we get them to do it is the challenge, right? We all want them to eat better and exercise more and sleep more and have less stress. And so but right but how do we actually get them to do it? You know, there’s this pervading idea that that we are not
Unknown Speaker  18:26
holistic,
Unknown Speaker  18:27
right? Like, right we have a sick care system where the health care so exactly, exactly, well,
Unknown Speaker  18:33
well put. And so it sounds to me if you’re recommending these things, for your patients that you are a holistic doctor to me because you are considering the whole patient and not just the one injury that you happen to be seen them for. So
Unknown Speaker  18:49
yeah, no, definitely. You know, it’s hard as a physician as well, when you’re, you know, push to see more patients and you have X amount of time with these patients and you know, it’s enough just to get the spine exam down. But I do try you know, I see a lot of patients, you know, with with metabolic syndrome that are obese you know, and, and that’s a lot of extra weight you know, if you’re if you’re every pound of weight over your ideal body weight in the daily biomechanics of going through your life can be up to four pounds extra on your spine. So don’t patients if you’re 10 pounds overweight, it’s like carrying a 40 pound backpack around. Imagine doing that all day your back would hurt. And these patients you know, you can do the math on patients are, you know, pretty, pretty heavy. So I asked them, you know, what do you what do you maybe you can, you know, try to cut out sugary drinks or try not eating after a certain time, small things, you know, it’s hard to go on a radical crash diet and they have a high failure rate but just being a little aware of how they can at least make some changes. And actually, in an upcoming episode, I’m going to be interviewing someone who specializes in obesity research, who will be talking to us about how we should be addressing that specific population, there was just a Huffington Post article going around around the my physician friends on Facebook about how bad doctors are about talking about obesity. And, you know, I think with regards that article is probably just a few standout callous individuals, I think most of us are saying things like you’re saying, right, like, trying to give them some advice that is reasonable and not discouraging, right. Like, you know, maybe not eating after nine o’clock at night. That’s a reasonable recommendation that that is easier for them to stick to as opposed to like, don’t eat carbs ever again, right? Like that’s really easy to lose 50 pounds I mean, it’s it’s a lot easier said than done. And I’ll say again, if you say in the wrong way, you can certainly get some poor online reviews for as a result, but is that it but I think if you say it in earnest, and you’re somewhat sensitive about a patient, understand, I may know piecemeal pitches, no one there, you know that they put it together. You know, being being obese being out of shape is, you know, one of the root causes of their back pain because it just makes sense.
Unknown Speaker  21:07
So, so let’s get back. So that’s for a later episode. I’m really looking forward to that, that, but I’m also really enjoying this interview. So Seth, let’s talk some more about some of the common concepts that you see. What would you say is the most common thing that you see something one of the most that you think would be useful to discuss?
Unknown Speaker  21:27
Well, I mean, again, I see obviously, all day long, I’m seeing neck and back pain again, just especially in this area is the usual it’s, you know, patient has neck or back pain and, and maybe they get to men’s ends or maybe, you know, and then they get an MRI and, and the MRI sounds terrible and they you know, and then they show up in my, my office, is there degenerative disc disease on an MRI, like, just if you
Unknown Speaker  21:53
just give me some statistic that you know, of,
Unknown Speaker  21:57
yeah, extremely, extremely common. I use the Patients age as the percentage. So if you’re 50 years old, you know, I took 100, healthy 50 year olds with no back pain at all and did them rise and then probably 50% would have significant degenerative this disease, if you’re at that number is 80%. You know, so So that’s sort of a rough thing. There’s some, there’s some studies to show but as a rough generalization, it’s your age is the percentage of patients your age, so they would have, you know, findings on an MRI.
Unknown Speaker  22:28
So those findings could be used to explain pain that’s there, but it’s not predictive of pain.
Unknown Speaker  22:34
Yeah, it’s a very good point. Very good question. And I’ll say, you know, makes makes the job tough sometimes, because, you know, it’s very common to see herniated discs. It’s very common to see degenerative disc bulging discs. And it’s, it’s not so easy. You know, in some cases, those are patients are in severe, you know, pain to the point where they need surgery for it. And in some cases, it’s an incidental finding where, you know, it was there already. And it’s just a muscle spasm. So it can be a challenge to, and some people for some reason, you know, feel it. pain receptors are different or whatever. But some patients are more sensitive to those to those changes, and some people are not. I think this was a very productive conversation and really appreciate you taking the time. Is there anything else that you wanted to discuss today that you think we might have missed? Yeah, I mean, just in general. So just to expound a little bit more on that visit. So you know, in general, if you’re a you know, 53 year old man and you pulled you back out, you know, shoveling snow and you ended up with an MRI, or likely not to a layperson even to another doctor. It’s going to sound terrible, that’s, you know, radiologists, you know, like to be thorough, and they like to describe everything and it’s going to see things like spondylitis is this creation, impingement. But really, you know, to tease out, you know, all that really the thing I when I went I, you know, obviously I try to read all my films, I look at all the reports examined the patient, I try to make it the most educated, you know, decision as possible. But at a glance when I look quickly at an MRI, what I’m looking for is things like stenosis and more central stenosis, like if there’s pressure on the canal on the on the in the middle of the canal where this where the spine runs down, if that if that’s being compressed, that can really be an issue if there’s any kind of obviously a fracture or a tumor that’s that’s a red flag for everyone but stenosis or significant you know, Mal alignment of his mind to spinal this thesis was whether we’re bones are slipping on each other. You know, I look for conditions where the nerve is compressed, because all that other stuff is is very common, and usually not not really a problem. Certainly not in the in the short term.
Unknown Speaker  24:50
Great. I really appreciate you taking the time to talk to me and talk to the audience. I think clearly polities in yoga now. We’ll have to find their way into my regimen somehow it’s not just going to be clean and jerk. And
Unknown Speaker  25:08
especially if you’re going to do create clean and jerk you gotta do some yoga employees in there as you get older. Well, you know, I can’t touch my toes. That’s a problem.
Unknown Speaker  25:18
It’s going to start catching up with me and clearly the Superman’s needs to find their way into my routine because myself and, you know, I’m sure almost all doctors would with the EMR even, you know, without the MRI dictate a lot of my notes, still hunched over my phone hunched over my computer, and you know what, we’re surgeons, hunched over our patients in the office and in the operating room.
Unknown Speaker  25:42
Yeah, your whole your whole life is spent in an inflection of your spine. So you definitely want to focus on the extension and try to try to keep that strength and mobility, very important.
Unknown Speaker  25:52
So all of us need to start doing the Superman before we go to bed. Maybe next,
Unknown Speaker  25:57
I want to see worldwide. I want to people doing Superman all those would be my wish tonight. All physicians in
Unknown Speaker  26:03
every everybody Superman minutes, right every night before bed.
Unknown Speaker  26:10
Yeah, that’d be that’d be I’d be out of a job where the light was busy.
Unknown Speaker  26:15
Maybe I don’t want people to do that. I think
Unknown Speaker  26:17
there’s a little conflict there.
Unknown Speaker  26:18
Okay. Well, thanks again. I appreciate you taking the time. It’s been a pleasure.
Unknown Speaker  26:24
Thank you so much. Thanks for having me.
Unknown Speaker  26:27
That was Dr. Bradley Block at the physicians guide to doctoring. Find all previous episodes on iTunes, Stitcher, Google podcasts, or wherever you get your podcasts and write us a review. You can also visit us on facebook@facebook.com slash physicians guide to doctoring. If you are interested in being a guest or have a question for a prior guest send a message or post a comment.
Transcribed by https://otter.ai

Present Your Medical Device Idea to Industry

Michael Graffeo is a 20 year veteran of the medical device industry.  He discusses how to put your best foot forward, prevent reproducing the mistakes of the past, and why it isn’t just important to just present why your idea is so great, but possibly even more important to discuss why it isn’t a risky idea.

Present Your Medical Device Idea to Industry

Michael Graffeo is a 20 year veteran of the medical device industry.  He discusses how to put your best foot forward, prevent reproducing the mistakes of the past, and why it isn’t just important to just present why your idea is so great, but possibly even more important to discuss why it isn’t a risky idea.

 

This is the transcript to the episode. This transcript was created by a talk to text application and the function of having this here is to improve the page search engine optimization. This transcript has not been proofread, so please listen to the episode and don’t read this. The information contained herein will inevitably contain inaccuracies that affect that quality of the information conveyed and the creator of this content will not be held liable for consequences of the use of the information herein.

Unknown Speaker  0:03
Welcome to the physicians guide to doctoring A Practical Guide for practicing physicians. We’re Dr. Bradley Block interviews experts in and out of medicine to find out everything we should have learned while we were memorizing Krebs cycle. The ideas expressed on this podcast are those of the interviewer and interviewee and do not represent those of their respective employers.
Unknown Speaker  0:29
Welcome back to the physicians guide to doctoring. On today’s episode, we have engineer and MBA Michael graphene who has 20 years of experience in the medical device space. He discusses why it’s not just important to have enthusiasm and a good sales pitch for why your new device is a great idea. But if you’re talking to investors, what are the ways that they can have their risk mitigated, he breaks down the four different classifications of risks you can really hone your sales pitch and why it’s not that important to worry about someone stealing your idea and how you You can minimize that risk as well. We discussed how to avoid duplicating the mistakes of the past and similar devices and how to get your idea in front of the right people. And why it’s not just important to have the idea, but to have the grit to move forward with it and stop making excuses.
Unknown Speaker  1:20
Welcome back to the physicians guide to doctoring. On today’s episode, we have Michael graph CEO, Mr. Graph EO started his education at Cornell he did his undergraduate in Engineering Physics and then got a Masters in mechanical engineering, and later in his career, got an MBA from Harvard. He started his career after college working for Johnson and Johnson went on to work in medical device sales for Hologic, the Vice President of Sales and Marketing for doing medical devices, Vice President of Sales and Marketing for over science, and then VP of business development for insulin, which is a drug delivery business unit. So he has a lot of experience as an engineer, working for metal device companies. And Michael, what is it that you’re doing now?
Unknown Speaker  2:04
Yeah, thanks, Brad. So I’ve been, for the last 20 years or so in various roles in the medical device industry. And for about six of those was in fairly small startup companies, both with my time at doing medical devices and over science. And, you know, earlier this year, I decided that I really wanted to get back into the small company startup business. And so just a few months ago, co founded a company called fluid form, which is actually in the regenerative medicine space, and we are licensing technology and bringing to market a new way to go about actually using desktop 3d printing technology to to approach regenerative medicine through 3d bio printing. So it’s very exciting technology, really kind of a novel, Greenfield space and one that we’re really excited to go make a difference in.
Unknown Speaker  3:00
Wow, that sounds that sounds really exciting. So, so regenerative medicine, what do you mean by that?
Unknown Speaker  3:07
Well, you know, the easiest way to think about it is in the long run, Imagine being able to take a 3d printer and plug in, you know, the right kind of bio ink into that and print tissue, printed Oregon, printer replacement, Oregon for transplant. That’s sort of the long run version or vision of a lot of the tissue engineering and bio printing Universe Today. I think there’s going to be a lot of really interesting technical hurdles engineering hurdles along the way and of course clinical. But in the meantime, you know, there’s there’s tremendous progress to be made, whether that’s printing things like collagen scaffolds or other types of engineered tissue to patches and then all the way out to, you know, organs. So, so not
Unknown Speaker  3:57
regenerating like an iguana grows new town. But rather regenerating like de novo you’re producing a de novo organ or tissue in the 3d printer for application. Exactly.
Unknown Speaker  4:11
Wow. That is.
Unknown Speaker  4:13
That’s exciting. That’s exciting. I’d love to delve more into that. And I think a great topic for later podcasts would be just where is the 3d printing space right now hat and how it applies to medicine? Because I think that’s, that would interest a lot of physicians. So, so, to our listeners, stay tuned for that one. But today, we’re just going to talk about how physicians, a physician with an idea for a medical device, how should the after that aha moment, where should the physician proceed from there? What are your options? So if you want to say rather than developing it completely on your own, maybe license The idea out to a device company, how would you proceed? What are your first steps?
Unknown Speaker  5:08
Well, I think, you know, when confronted with this situation, and I’ve been very fortunate, in my experience, both with big companies, and with small companies and entrepreneurs to have seen versions of this a number of times, I think it’s important to start before saying, How do I go about doing it? to actually ask the question, why do I want to do this in the first place? One of the most common misconceptions that I’ve seen is the notion that I’ve got this great idea, and therefore, it’s worth a lot of money, and I’m going to get rich, or I’m going to supplement my kids college fund with this. And that can happen, but it’s probably not going to. And I think it’s really important to remember that right off the bat that if you’re simply trying to Bring something novel to the market because of the financial gain at the end of the day is hard. And it takes a lot of persistence and stick to it Ignis. And things go wrong that are way beyond anybody’s control. And so there has to be a bigger why there has to be a bigger reason for putting this kind of time into something, putting this kind of effort into something. And so I just want to just really emphasize up front that the most successful innovations that I’ve seen, have really come out of somebody having a burning desire to pour whatever time and energy it takes into seeing something become a reality either for the the intrinsic benefit or pleasure of seeing that happen or bringing that solution to people to solve that problem. Or from the you know, the clinical perspective have seen patients benefit from it be worth living struggling otherwise. But But seldom is the kind of personal financial ruin. iteration, an effective driver in the long run of making something happen. It’s kind of like this podcast.
Unknown Speaker  7:09
I’m doing it because I enjoy it. There is currently and likely will be zero monetary gain. And there’s just like the idea of bringing people like you with great ideas and great knowledge to share in touch with other physicians that you know, you may be answering a lot of questions they might have in a very digestible way. So, okay, So rule number one, set your expectations low, and make sure that you’re doing it for the love of it, not for the monetary gain. Okay. Now, but let’s say you, you recognize that But still, it’s something you’re extremely passionate about. And let’s say you even know someone in that works for a medical device company. What are some of the pitfalls that you see that that people should manage before They bring the idea to someone.
Unknown Speaker  8:02
Sure. Well, I think you know, one of the first things that you really want to think about, because the pitfalls are going to be different depending on the very first question, which is, what do you want out of this, you know, at the core, as a practicing physician, you know, you get to answer the question, do I really want to give this idea to somebody else? And let them run with it and be, you know, they’re in an advisory capacity? Or put in another way? Do I want to sell or license this idea to somebody? Or do I want to be the one on the hook of making it happen? And the third choice is, do I want to sit on it and tell my friends 20 years from now, I had that idea, someday in the future when somebody actually has done it on this on their own. And you’d be surprised how often that actually is the default choice because somebody can’t make the decision between seller licenses to somebody else, or double down and actually make it happen. There. But if you if you talk about those two real, you know, effective choices, either partner with somebody else, either a big company or a small company and be an advisor to it, or make it happen yourself, the pitfalls are very, very different. The pitfalls in selling and licensing the idea, well there it’s about selecting the right third party partner, whether it’s a big company or an entrepreneur, a venture capital firm that wants to put something together around it. It’s about selecting the right people to run with the idea when it’s make it happen yourself. It’s ultimately going to come down to selecting the right people but it’s the right people to work with you to make it happen. And frankly, I’d say you know, if you want to make something happen yourself, the pressure of you know, building a practice which is hard enough today, and maintaining any semblance of a personal life, whether you have a family or not, and attempting to you know, make an idea come to reality and a fledgling company. That’s, that’s a big, big, heavy ask, and something that should not be entered into lightly. So let’s
Unknown Speaker  10:07
start with a simpler one. Let’s start with just, you want to license your idea to a medical device company first. How do you? How do you be sure that they’re not just going to say, that’s a great idea? Just going to take it from you. You know, that happens all the time. In Hollywood, you see, scripts come out all the time, two or three very similar movies all released at the same time. If the if if the studio doesn’t like your script, they’re not going to buy it from you, but they can still sell your steal your idea, hire someone else to write it the way they want to see it. And there’s no recourse for you as long as they make it, you know, different enough that it’s not obviously obviously stolen. So so if I have a great idea for a widget and I approach someone about it, how do I secure that and I recognize you’re not a lawyer, right? Like, I’m I’m shorter on specifically what I’m asking you, but kind of still am. What I’m asking you, I should probably get a lawyer on the show because the last person that I had about social media, I asked her, you know, what are the legal pitfalls? But for for you, right? How do I make sure that that this isn’t just going to get poached from me?
Unknown Speaker  11:20
Yeah. And I think that, you know, the, the fear of the idea getting stolen is probably the biggest reason why you’ll find people who are sitting here today saying I had that idea 20 years ago. Yeah. And I had it before they did. And I think it’s an important, you know, lesson to learn, because what that scenario tells you is that the value of any idea is a lot less than the idea itself, and a lot more in the making the idea comes to life. Right? The entrepreneurs who are really, really successful in this world know that it Ideas are not a dime a dozen. But there’s no shortage of ideas in the world. what’s the what’s the world is short on is people who take good ideas and make them become reality. And so that’s not to say you’ve got a great idea. Yes. So what, in fact, quite the opposite, you got a great idea that’s a prerequisite for doing something with it. But it is important to say that, you know, showing up to a big company that, you know, let’s say you’ve got a great idea in the cardiovascular space, and so you show up to a company that has a valid franchise or a student franchise or otherwise, he said, I’ve got a great idea for how to how to make something better, fairly skeptically and say, Well, okay, listen, first off, you know, I’ve got an engineering team and debate in the back who has 1000 ideas on how to make this better. And as a company, we’ve got to choose how to prioritize the right idea that we can invest in and take out to the marketplace and actually make a return on. So I would say the first thing you’ve got under Stand when you have an idea is how does this idea create value. And when I say create value, not just to me, the working physician who might say, I’d really like this device to have a slightly different angle here, or a different vendor this way, or I could do a whole different procedure, if I only had this one sort of complements to this other part. But to say, you know, in the world of healthcare today, I’m just having a slightly better device is not necessarily enough to even get a big company to invest in it even if they already have the idea. So, you know, you would use the example earlier read have a novel procedure, like an office based balloon signing Class D. Right? That’s a great example of value being created for patients who now can be treated in a outpatient setting to address something that was previously not being addressed. And was causing a lot of overhang. And so you’re actually creating, you can demonstrate value being created in the marketplace. That way. You can demonstrate, you know, either transition from inpatient outpatient procedures, or people who are not being treated and therefore having a lot of costs associated with it, who now can be treated. That’s the kind of condition that is going to be a lot easier to get a company behind, then incremental improvements.
Unknown Speaker  14:28
So So when you’re creating your PowerPoint, to present to the company, you need to be able to identify the epidemiology, the statistics behind how many people are affected by this, how severely they are affected, how much it costs. And you need to have all that information at your fingertips because you need to have established exactly how much this this value is. You know, how long is a to continue with the balloon to play See, one of the things that it did is it It took what was previously done only in the operating room is and it took him to the office. I’m not advocating for this procedure, nor am I taking anything away from it, but we’re just using it as an example. Right? It took things that were only done in the operating room, it brought them to a place where they can be done in the office on select patients. And so the the value for an insurance company to now pay for this procedure is you no longer have to pay for anesthesia, you only have to pay for a facility fee. So even if the device costs a certain amount of money, you’re now saving the insurance company. So you can argue that well the device can cost up to this amount, because now the procedure to treat this is costing in total that this much less and this is how many people get chronic sinusitis. This is how many people get sinus surgery year and this is percent of the population we would expect to be able to tolerate and be appropriate for this now, outpatient procedure. This is how much money can be made from this This is why you should take my idea and help me run with it. So you need to be very what you’re saying is, when you when you, you need to get as granular as possible with your data to make the financial argument as to why this should be why this is a good idea.
Unknown Speaker  16:20
Yeah, I think that’s right. And I think, you know, to, to maybe put a little finer point on it. If you’re going to a Johnson and Johnson or a Boston Scientific or a Medtronic or an Abbott or any one of the kind of premier med device companies out there, they’ve got plenty of people who understand this landscape. So if your goal is to license something to a big company like that, you probably don’t need to go buy thousands of dollars of market research reports and get the the statistics down to the granular level. You do need, however, to be able to paint the picture and you need to be able to paint the picture so that they can then go do the work. work, because they’re going to want to vet the the numbers and the epidemiology and all the rest of it to assess whether it’s a really compelling idea or not. If you were presenting the same idea to an investor to attempt to raise money, yes, I would say you want to have all of that locked and loaded so you can paint the most compelling picture. But when you’re talking to a big company, that they’re going to have a pretty good feel for the the general market space market dynamics. But what you really need to do is to be able to paint the picture to say, here’s what the value that we can create is, and here’s why my solution is going to be able to mitigate is going to be able to achieve that. And there’s always going to be the notion and we talked a lot about it in the industry of de risking investments. It’s a it’s a made up business word around saying we know that there’s four major categories of risk to any new innovation. And so the more you can address as somebody with the idea can address why these are Actually not as risky as a typical investment might be, the more you’re going to be able to get somebody on board with the vision. So those four areas are going to be things. The first is technical or feasibility, right? Can you actually design a solution that can be designed and that can be robustly manufactured? that’s actually going to deliver the result you’re looking for repeatedly? And so, you know, it’s a very different question when you have to invent some new chemistry to achieve a solution you’re looking for. versus if you need some really good engineers to sit down in a 3d modeling piece of software and design up a great drawing, right? There’s a very, very different technical risk profile. The when there’s invention required, the technical risk is going to be scored very high. And the second category is clinical risk, right? So imagine you’re able to invent the device that needs to be invented or design the device that needs to be designed. How difficult is it going to Be to run a clinical trial, that’s going to show me that it works. And so that’s there’s two parts. Number one, you know, how likely is it that we’re going to see a treatment effect? And number two, how big a trial Am I going to need? Is this going to require 600 patients and a double blind randomized trial in 30 centers? Or am I going to be able to show this is such a profound treatment effect, that I’m going to be able to do it in 80 to 100 patients in three centers, a very different risk profile and one that a company will look at really carefully. The third is actually related to clinical risk, which is regulatory risk. Is it clear that the FDA is going to know what to do with this new category of device that you’ve come up with? Is there a predicate device on the market and so it’s going to be a very similar approval process to something that already exists? Or is this totally breaking new ground and we’re going to need to be educating biostatistician at the FDA along with bio statisticians inside the company. In order to get to this process, I’ve actually been a part of both and I can tell you when you need to educate the agency on how to think about a new innovation, it’s a much riskier proposition and then you think okay you know satisfied technical we’ve satisfied clinical, we’ve satisfied regulatory, that’s that’s a huge mountain to climb. Well, unfortunately, that’s that’s actually the smallest three mountains because the fourth mountain becomes the market adoption risk. Most inventors look at an invention and think about it from a if you build it, they will come perspective. However, in today’s day and age, and every practicing physician I know is very, very aware of the value based care mentality that’s pervading the healthcare system today. Just because you invent a great product does not mean that its patients are going to have access to it. And so you need to think about what it’s going to take to get either insurance companies to pay for it or To make it so that in a, you know, capitated kind of environment, that the hospital or the office who’s buying it is actually going to be saving money out of their capitated payment. Because if you’re adding costs to the system, it’s going to have to be an absolutely incredible benefit for people to start thinking about adding cost system today.
Unknown Speaker  21:22
Wow. So, you know, it makes me think of, I think it was Warren Buffett That said, the key to investing is don’t lose money. And so it sounds like you have to say the same thing. If you’re talking about a medical device, when you’re making the argument for why should be developed. The key to the argument isn’t this is why it’s an amazing device. The key is, this is why the risks associated with developing it are mitigated or low. You have to before you can start talking about the benefits you have to start you have to start out by Minimizing the risks.
Unknown Speaker  22:02
Yeah, the interest, both of them are really important, right? I mean, you know, the by very nature, anybody who has sort of an invention or an idea, generally is going to be very good at proselytizing the benefits of that. Yeah. And the challenges like that, that’s really important. But that’s also where most people stop.
Unknown Speaker  22:20
Yeah, so I should I say, my money.
Unknown Speaker  22:23
Exactly. I don’t want to say don’t do that. Because if you show up and say, Well, here’s all the reasons why what I’m about to tell you isn’t very risky. That’s going to be pretty underwhelming. But But when you’re when you’re done proselytizing, what’s great about you know, the idea that you have you if you really want to try to move the needle, you’ve got to be able to kind of tell that story. And here’s, here’s why it’s doable. Yeah, here’s why we can actually execute on this.
Unknown Speaker  22:50
And then at what point in that do you have to contact a patent attorney, right? That’s what that’s one of the things that I was You know, when you do approach that company that we were talking about earlier? I mean, I think,
Unknown Speaker  23:04
actually, could you just recap those four risks? One more time? Just for our listeners? Sure. Yeah. So the four risks, the four categories are technical and feasibility. In other words, can you actually design something to do what you want it to do repeatedly and reliably? The second risk is clinical risk. So can you design a trial that will actually demonstrate the performance of the products both safety and efficacy? The third is regulatory risk of can you actually get the agency to approve a device like this? And the fourth and one that most people lose track of at the inventor idea stage? Is market adoption risk? What’s it going to take to get patients access to this product in the marketplace? And then what kind of, you know, sales effort is it going to take to actually, you know, get this adopted?
Unknown Speaker  23:55
And as physicians, we see that all the time in our offices is either device Certain medication sales reps coming by over and over and over. So that there’s there’s certainly a lot that’s just a little glimpse of, of the process that it takes in order to get market adoption. And and these frequently are medications that have been around for a long time. So it’s a continuous, clearly a continuous process. But But if you do have that idea, you know, at what point should you be contacting a patent attorney? Because that is an expensive proposition. Right question. You said it before, right? Like, people come up with great ideas all the time, but they don’t have the wherewithal or the grit to really push them through the next stages. And one of those stages is going to be protecting your idea. And a patent attorney. I don’t think is is cheap. So at what point is that necessary to protect yourself before you go telling everybody your great idea?
Unknown Speaker  24:55
Yeah, so I think there’s a couple of pieces to that that you want to kind of balance right so So number one, as we said earlier, I’m not a lawyer and I nothing that I say should be construed as legal advice.
Unknown Speaker  25:08
What I can say, though, is,
Unknown Speaker  25:12
in today’s day and age, it’s remarkably easy for anybody with an idea to get a preliminary sense of what the patent landscape looks like, right? Google patents is a great resource. If you get an idea, and you spend an hour or two one night, on Google patents, you should be able to figure out a if anybody else has ever had an idea like this, and be if there’s anything similar to it, that you could base sort of a conceptual patent structure based on and so you know, if you have the idea that hey, there actually is the potential for some freedom to operate. And that’s the legal term for you know, there’s a patent landscape or Where the idea that I have might be patentable? You know, then the next step really is to reach out to a patent attorney and have a preliminary conversation. You know, most lawyers will have kind of an initial kind of exploratory discussion without before signing any sort of an engagement. And and I would say, you know, with a lawyer is always a good idea to be super open and say, This is what I’m working on. And, you know, I’m I’d like to get a provisional patent filing in place. And I think it’s an important sort of distinction for anybody who’s not working in and around the space, right, a patent application to fully prosecute that to the point where you have an issue granted patent is fairly expensive. But to get a provisional patent application, put in place is not as expensive as you might think. To get it, what a provisional means is effectively you know, we live in a world where patents are granted based on what’s called first to file so if two competing ideas that the two guys have the same idea They submit the same patent application, the first one to get it into the patent office wins. Right, it used to be the first one to have the idea one, and then they’d have lengthy arguments over who had the idea first. Now, it’s just whoever files it first. So there’s a whole process to submit what’s called a provisional patent. What that does is kind of it saves your space in line. It says, I had this idea I am submitting it, this is the basic structure of it. And then you have a certain amount of time after that tales and get a fully fledged patent. And so I’d say if you’ve done the work on, you know, looking through Google patents, you’ve got you get the sense that this is a patentable idea, or maybe, you know, then it’s worth it to spend a small amount of money to get a couple of drawings made up and to to put together a the basic structure of a provisional patent. You know, in this case here, we’re not talking about, you know, 20 $30,000 we’re usually talking about, you know, take a zero off That. And that gets you the ability to say, Listen, I’ve got a provisional patent filed on this. And there now you should, you can feel a lot more comfortable talking about the the working details of it. So that that’s kind of the patent side, but I think it’s also important to say legally called Dibs. Yeah, exactly, exactly. This is this is the shot gun.
Unknown Speaker  28:27
But I also think it’s important to say, you know,
Unknown Speaker  28:31
anybody working in kind of the entrepreneurial space within, you know, trying to raise money with investors knows that you get kind of the same dance, right? I’d like to share with you a whole bunch of stuff about my company in order to make you want to invest in it. But, you know, I, you as an investor only want to see the non confidential stuff that I can share. Because you look at 1000 investments a year and you don’t want to be tainted by having non disclosure agreements with anybody and everybody Well, the same thing is going to be true Most ideas that are generated by a physician talking to a company, they’re usually not going to want to sign a nondisclosure agreement right up front. And in the few that do, what they have is they usually have processes in place, which means that the people who are going to hear the pitch, if it’s in a non disclosure situation, are people who are going to be, you know, not in any way qualified to technically evaluate it. So I’ve seen it some organizations, they’ll sign a nondisclosure, but then they’ll assign like a special group of people who have nothing to do with anything that’s going on at the company to evaluate this idea, because, you know, let’s suppose I’m the head of r&d at a big company, and we’ve got 25 research projects going on. Well, if my company signs an NDA with an inventor who comes in and pitches something, and we decide not to do it, and that was evaluated by you know, a couple of people but I had three projects that were substantially similar to that going on? Well, now my company is really at risk, right? Because I’m going to bring something like that to market two years from now. And the inventor with the idea is going to come and say, Hey, that was my idea. And I shared it with you, under nondisclosure, and you stole it from me. Right? So companies know about this risk, and they don’t want to expose themselves to it. So you will either find that companies won’t sign a nondisclosure agreement, in which case you have to figure out how to have a non confidential discussion of your invention. Or they’ll sign a nondisclosure agreement. But none of the people who are actually knee deep in this kind of project will review it. And therefore, it’ll be either a business development person or a marketing person from another division, or maybe a technical person that is a consultant to them that they bring on to come in and take a look at this. So you know, that’s a balance and that’s a trade off you got to decide whether you want to insist on having a confidential discussion. We can get into the details. Or if you’re going to find a way to have a non confidential discussion, you describe the idea in concept. But you keep it sufficient that even if they had, if you gave them this non confidential information, they wouldn’t really know how to actually do it without talking to you more.
Unknown Speaker  31:17
God. So you’re, what you’re really saying is, you’re more protected than you think you are. Because that they’re, they’re, in essence trying to protect themselves as well. And their ability to invest in this space.
Unknown Speaker  31:31
Yeah, I will say, you know, the, the, the idea of the big company as sort of the Big Bad Wolf who’s just out to steal ideas from anybody who might happen to inadvertently share with them, you know, it’s grounded in some experience. There’s certainly folks who have had ideas stolen and who are rightfully upset about that. But by and large, I’ve seen, you know, every organization I’ve ever participated with, I go to great lengths to avoid that because they don’t want that. That’s not good. for their business in the short term or in the long term, and it’s certainly not good for their relationship with the physician community. And they rely on that relationship for a lot of what they expect to do, again, short term and long term. So I would never say you know, walking unprotected and just count on the the processes that are in place to protect you. But I would say if you if you do the right thing, and either file provisional patents, or let’s suppose that your ideas are not patentable, but that you’ve got some unique amount of know how on how to make it happen, right, so then you say, all right, I’ve got these trade secrets on how to actually do this. And I’m not going to share those with you in the conversation until we get further down into the into the process, because those are those are my trade secrets. Right. And this is very common with with a lot of industry where, you know, the How to manufacture it, or the how we make the design work where other people have failed, those sorts of things. Maybe we can’t patent it, but because we know how to do it. We’ve we can prove that it works.
Unknown Speaker  33:03
That becomes a unique defensible position.
Unknown Speaker  33:06
I think we’ve ended up spending most of the time, mainly discussing, not device development specifically but more idea development and approaching really someone like you, or someone else in your field who can then run with that idea how to protect yourself why it’s really not as necessary as, as I thought to be as on such a defensive position. But because because we’re going to be wrapping up. Do you have any final thoughts? Anything that that I didn’t ask you that it is important for a physician to know maybe some common pitfalls? If you do have that idea? You’re going to be approaching the company. And, you know, maybe some common mistake or two that you see on your end from the physician side?
Unknown Speaker  33:58
Sure, yeah. You know, the
Unknown Speaker  34:01
I think about innovations as either zero to 100 innovations, you know, doing something that nobody has ever done before, or one too many innovations, ie, there’s something that’s been done before, I’ve got an idea on how to do it better, how to do it faster, how to do it easier, how to do it less expensive. And I would say the vast majority of the innovations that, that I’ve seen, the vast majority of the ideas and companies that I’ve ever seen in my career are the one to many kind, zero to one innovations are very unique, and I’ll set those aside for a minute.
Unknown Speaker  34:41
When it comes to a one to many innovation,
Unknown Speaker  34:44
one of the things that I’ve seen over and over again, is that folks who have those ideas and who are trying to make them happen. Don’t pay attention to history. And I think that’s a really big pitfall Oftentimes, there are really good reasons why things are the way they are. And if you’re seeking to change the way things are, you may be wildly successful at it. But it’s really important to understand why things are the way they are in the first place. If you’re looking at a category of product that had an FDA Advisory Committee, for the approval of the first product of its kind, go back to the FDA website, find the FDA panel pack, read the transcript of that meeting, you’ll probably learn a lot you’ll probably understand where some of the misgivings were. where some of the problems with the clinical trial design, where were some of the operating problems of the product might be go out and look at things like the FDA mod database. That’s the database where manufacturers and users report device problems. Understand what kind of problems happen with categories of devices that you’re looking at. Talk to people who’ve tried to do develop these products before, you know Google search will give you, you know, 10 2030 companies in a given space who’ve tried and failed. And finding failed companies in a given space is a great learning opportunity to understand and what really happened there. A lot of those folks, if you connect with them in LinkedIn and drop them in a note and ask, Hey, like to talk to you, I’m kind of working on something in this space, they’re happy to share what went wrong, the more you can understand about where the pitfalls are, the better because when you go to a big company, you’re going to talk to somebody who is well educated on that space, and who may have looked at all those companies before that failed. So when they look at you, they’re going to say, Well, I don’t understand how this is any different from things I’ve already seen before, passed on and then watched fail. And so I’d say that’s a huge pothole that a lot of people aren’t aware of. I run into that over and over again.
Unknown Speaker  36:50
So that I think leads into and just correct me if I’m wrong into what my final question was going to be, which is, how do we get in touch with the Right company. And I think you kind of implied that in there is if you have a similar if there was already a similar idea out there, they had their trials, they had their problems. You get in touch with someone on LinkedIn who would develop the similar device. That person is probably going to be well acquainted with the industry, and is going to be able to point you in the right direction. And I think it’s from How to Win Friends and Influence People, right? There’s no sweeter son sweeter sound and the sound of your own name. So you ask someone who developed a device I’m sure they’re passionate about. I’m sure they’d love to talk about it. get their input on it, read everything about it beforehand. Certainly they’re going to be flattered that you did this research on their great idea. And then you connect with them, you talk to them, you pick their brain, and then they can probably point you in the direction of what next steps you can take.
Unknown Speaker  38:01
In your journey, would you would you agree with that?
Unknown Speaker  38:04
Yeah, I would, I would say that some of those folks might even be willing to make a few introductions for you. But I’d also add that in addition to those folks, you know, the simplest way to think about who to reach out to, is to look at who is already selling products that are like yours. Because at the end of the day, these large businesses, they have sales forces that cost a lot of money, and they’re always looking to give that Salesforce more to sell. That’s their best way to get, you know, more return on the investment in the Salesforce. So if you have a product that would be sold by, you know, a rep from, you know, one of the large major companies if you have an idea for a product that would be highly complementary to that. You want to talk to those companies. And that’s where you know the idea of talking to you know, you will not take the same product and talk to striker as you would going and talking to Hologic, because their products don’t overlap, they don’t compete with one another. And you might have a very different conversation with Medtronic than you would with Philips, again, because they have just a fundamentally very, very different product set. So, you know, understanding who makes products in this space, and then, you know, narrowing down your search that will help you know who to go talk to
Unknown Speaker  39:27
great. This was extremely enlightening. We really didn’t cover one thing that I I that I wanted to that we talked about beforehand, which was bursting people’s bubbles as to how challenging it can be to take your idea and, and and make it real but that’s that’s totally fine. That was this was a very, I think encouraging talk. You really gave a lot of positive ideas as to how people can make their their dreams reality at least At least rather than developing it themselves, but but developing really fleshing out their ideas, mitigating the risks and then selling their idea to someone who can who can take it to completion.
Unknown Speaker  40:13
Well, I think that after, you know, after making the the assertion at the beginning, that you’re not going to make any money doing this anyway, I’m glad to hear that most of the rest of the tone was optimistic. Yeah.
Unknown Speaker  40:26
So as long as it’s your passion, and that’s why you’re doing it and you’re not expecting to make any money and be able to retire on this alone. But you also can be a foot in the door in that space and making connections and, and great things happen from there. So Mike, thanks so much for for talking to me and taking the time to do this and enlighten us how we can really take our ideas and and make them real and good luck with fluid form. I really look forward to seeing what you
Unknown Speaker  40:55
do in the biologic 3d printing space.
Unknown Speaker  40:58
Thanks so much. Have a pleasure. Online this has been a blast.
Unknown Speaker  41:04
That was Dr. Bradley Block at the physicians guide to doctoring. Find all previous episodes on iTunes, Stitcher, Google podcasts or wherever you get your podcasts and write us a review. You can also visit us on facebook@facebook.com slash physicians guide to doctoring. If you’re interested in being a guest or have a question for a prior guest, send a message or post a comment.
Transcribed by https://otter.ai